About this trial
Cannabis sativa is an annual herbaceous plant from the Cannabaceae family that has been cultivated and consumed by humans for thousands of years. Its main uses include fiber production, seeds for human and animal food, and psychoactive medications. Indeed, cannabis is the most commonly consumed illicit substance among adolescents and poses a major public health issue. Allergic risks associated with cannabis have already been documented.
At the same time, the consumption of hemp seeds is increasing due to the current agro-food context and the rise of vegan and vegetarian diets. This new food raises questions about its potential allergic risks, especially since the prevalence and severity of food allergies have been steadily increasing over the years. In this context, cases of anaphylaxis related to hemp seeds have already been reported. However, the potential allergic risk associated with hemp seeds remains largely unstudied to date.
Several reasons make research into hemp seed allergies relevant:
i) increased exposure to Cannabis sativa in its various forms, with the possibility of finding identical or similar proteins in the seeds; ii) changes in dietary habits, with the vegan trend encouraging the consumption of many seeds, including hemp seeds.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 2 years or older
Patients referred to the Allergy Unit at Angers University Hospital (CHU d'Angers) for skin prick testing, either in outpatient consultation or during hospitalization
Patients affiliated with or beneficiaries of a social security system
Patient or legal representative having signed an informed consent form
Disqualifiers
Pregnant women or women in labor
Individuals deprived of liberty by an administrative or judicial decision
Individuals undergoing involuntary psychiatric care
Adults under a legal protection measure
Trial design
Single group
Treatments tested in this trial
blood sample and skin prick tests
Diagnostic testBlood sample and skin prick tests in addition to the blood tests and skin prick tests originally scheduled for the patient's care
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients sensitized to hemp seeds in 3 differents population of patients (cannabis , tree nuts and seeds allergy)
This sensitization is assessed using three independent methods, each with predefined positivity thresholds of which i) Skin prick tests using native hemp seeds with positive results defined as: Wheal diameter ≥ 6 mm and Erythema larger than the wheal A patient will be considered to have a hemp seeds allergy if the prick test is positive (regardless of the results of the other two tests) or if the other two tests are positive while the hemp seeds prick test is \< 6 mm.
Proportion of patients sensitized to hemp seeds in 3 differents population of patients (cannabis , tree nuts and seeds allergy)
This sensitization is assessed using three independent methods, each with predefined positivity thresholds of which ii) IgE reactivity to a total protein extract of hemp seed (≥ 10 ng/mL) A patient will be considered to have a hemp seeds allergy if the prick test is positive (regardless of the results of the other two tests) or if the other two tests are positive while the hemp seeds prick test is \< 6 mm.
Proportion of patients sensitized to hemp seeds in 3 differents population of patients (cannabis , tree nuts and seeds allergy)
This sensitization is assessed using three independent methods, each with predefined positivity thresholds of which iii) Basophil activation test (BAT) with a positivity threshold set at \> 10% degranulation. A patient will be considered to have a hemp seeds allergy if the prick test is positive (regardless of the results of the other two tests) or if the other two tests are positive while the hemp seeds prick test is \< 6 mm.
Secondary outcomes
Proportion of patients sensitized to hemp leaves
To estimate the proportion of patients sensitized to hemp leaves among: subjects allergic or suspected of being allergic to cannabis (including hemp), subjects allergic to tree nuts (e.g., hazelnuts or walnuts), subjects allergic to seeds (e.g., sunflower, sesame, etc.)
Describe the IgE reactivity profiles to hemp leaves
IgE reactivity profiles based on four tests : 1. total protein extract of male hemp flowers (≥ 10 ng/mL); 2. total protein extract of female hemp flowers (≥ 10 ng/mL); Commercial extracts used in routine clinical practice: 3. Hemp extract (ImmunoCAP) (\> 0.35 kUA/L); 4. Can s 3 (ImmunoCAP) (\> 0.35 kUA/L).
Identify the allergenic protein components mediating IgE reactivity to hemp seeds and hemp flowers
1. Indirect fluorometric ELISA 2. Western Blot 3. Human mast cell or humanized rat basophil assays
Locations
Sponsors and contacts
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